Trial · NCT01426763
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
NCT01426763, Phase 2, Completed, Shire; results first posted 2013-01-04
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase. Trials, record NCT01426763. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01426763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
- NCT number
- NCT01426763
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- CINRYZE with rHuPH20
- First posted
- 2011-08-31
- Last updated
- 2021-07-19
- Results first posted
- 2013-01-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | 18 days | |
| Secondary | Mean Change C1 Inhibitor (C1INH) | 18 days | Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. |
| Secondary | Mean Change C4 Compliment | 18 days | Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. |
| Secondary | Number of Subjects With C1 INH Antibodies | Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | 18 days | participants | NUMBER | |
| SECONDARY | Mean Change C1 Inhibitor (C1INH) | 18 days | Intent to Treat | g/L | MEAN |
| SECONDARY | Mean Change C4 Compliment | 18 days | Intent to Treat | mg/L | MEAN |
| SECONDARY | Number of Subjects With C1 INH Antibodies | Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | Number of participants with adverse events | 6 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | SC CINRYZE With rHuPH20 Dose Level 2 | Number of participants with adverse events | 5 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | Number of participants with injection site reactions | 6 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | SC CINRYZE With rHuPH20 Dose Level 2 | Number of participants with injection site reactions | 5 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | Number of participants who discontinued study drug | 0 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | SC CINRYZE With rHuPH20 Dose Level 2 | Number of participants who discontinued study drug | 0 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | Number of participants who withdrew from the study | 0 | participants | |
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | SC CINRYZE With rHuPH20 Dose Level 2 | Number of participants who withdrew from the study | 0 | participants | |
| Mean Change C1 Inhibitor (C1INH) | Subcutaneous (SC) With Recombinant Human Hyaluronidase ph20 (rHuPH20) CYNRYZE Dose 1 | 0 Hour (h) | 0.0248 | Standard Deviation 0.0565 | g/L |
| Mean Change C1 Inhibitor (C1INH) | SC CINRYZE With rHuPH20 Dose Level 2 | 0 Hour (h) | 0.00483 | Standard Deviation 0.00904 | g/L |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 6 | |
| Overall Study | STARTED | SC CINRYZE With rHuPH20 Dose Level 2 | 6 | |
| Overall Study | COMPLETED | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 6 | |
| Overall Study | COMPLETED | SC CINRYZE With rHuPH20 Dose Level 2 | 6 | |
| Overall Study | NOT COMPLETED | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | SC CINRYZE With rHuPH20 Dose Level 2 | 0 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 5 | 6 | |
| other | Injection site erythema | General disorders | SC CINRYZE With rHuPH20 Dose Level 2 | 5 | 6 | |
| other | Injection site hemorrhage | General disorders | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 1 | 6 | |
| other | Injection site hemorrhage | General disorders | SC CINRYZE With rHuPH20 Dose Level 2 | 0 | 6 | |
| other | Injection site induration | General disorders | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 0 | 6 | |
| other | Injection site induration | General disorders | SC CINRYZE With rHuPH20 Dose Level 2 | 1 | 6 | |
| other | Injection site edema | General disorders | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 1 | 6 | |
| other | Injection site edema | General disorders | SC CINRYZE With rHuPH20 Dose Level 2 | 0 | 6 | |
| other | Injection site pain | General disorders | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 4 | 6 | |
| other | Injection site pain | General disorders | SC CINRYZE With rHuPH20 Dose Level 2 | 1 | 6 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | ||
| Total, all-cause mortality | SC CINRYZE With rHuPH20 Dose Level 2 | ||
| Total, other adverse events | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 6 | 6 |
| Total, other adverse events | SC CINRYZE With rHuPH20 Dose Level 2 | 5 | 6 |
| Total, serious adverse events | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | 0 | 6 |
| Total, serious adverse events | SC CINRYZE With rHuPH20 Dose Level 2 | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 vs SC CINRYZE With rHuPH20 Dose Level 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01426763
GET https://conductscience.org/api/trials/v1/NCT01426763/results?page=2